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Completed

NCT Number: NCT07213180

Study of the Return to Driving in People Who Have Suffered a Cerebrovascular Accident (CVA)

The RETROUVE study will provide healthcare professionals, patients and their families informations on the rate of return to driving in people who have suffered a stroke, and will provide a better understanding of the various factors that explain this return. This bi-centric study is being conducted in 2 parts: a retrospective part involving an analysis of medical records, and a prospective part involving a telephone questionnaire.

The main aim of this study is to assess the rate of return to driving in patients who have suffered a stroke, following an assessment of their fitness to drive. It will also aim to study the factors that explain a return to driving in post-stroke patients.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Ploemeur, Brittany Region, 56275, France

About this study

This study aims to evaluate the rate of return to driving among stroke patients who underwent a formal fitness-to-drive assessment at the Kerpape CMRRF or Henry Gabrielle Hospital in 2019. Stroke patients may experience impairments in motor, cognitive, and executive functions, which can affect their ability to drive safely. The assessment involves a multidisciplinary evaluation including medical examination (vision, hearing, motor coordination), neuropsychological assessment (executive functions, attention, processing speed), and an on-road or simulator-based driving evaluation conducted by a driving instructor and occupational therapist.

The study consists of two phases:

Retrospective Analysis: Medical records of patients who underwent the driving assessment in 2019 will be reviewed. Collected variables include demographic characteristics (age, gender, education level), clinical data (stroke type, severity, comorbidities, medications affecting alertness), and driving assessment outcomes (favorable, unfavorable, or favorable with restrictions). The analysis will compare patients who were judged fit to drive with those who were judged unfit, in order to identify factors associated with a favorable driving outcome. Statistical methods include Chi-square tests, Student's t-tests or Wilcoxon tests depending on data distribution, and logistic regression to identify influential clinical, demographic, and driving-related factors.

Telephone Follow-Up: Approximately three years after the initial assessment, participants will be contacted by telephone to complete a follow-up questionnaire. The questionnaire evaluates current driving practices, limitations, perceived difficulties, and strategies adopted since the stroke. Telephone interviews are conducted by research staff and last approximately one hour.

All participants identified through medical records are informed about the study and their non-objection is recorded in the medical file. Data collection and analyses will adhere to the intention-to-treat principle. Missing data will be included in analyses, and any additional exploratory analyses will be clearly documented in the final report.

The study provides insight into long-term driving outcomes after stroke, the adaptation strategies patients implement, and the demographic and clinical factors influencing successful resumption of driving.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged ≥ 18 years and ≤ 85
  • Having suffered a stroke (ischaemic and/or haemorrhagic)
  • Having completed a driving assessment in 2019 at one of the 2 centres participating in the study
  • Have not objected to taking part in the study

Exclusion criteria

  • Protected adults (guardianship)
  • Insufficient command of the French language
  • Deceased patients

Treatment and study plan

Primary outcomes

  1. Rate of return to driving after stroke

    Time frame: From date of stroke to date of driving assessment in 2019, assessed retrospectively.

    Proportion of stroke patients assessed as fit to drive (favorable decision) by the multidisciplinary team and the registered physician, based on the 2019 driving assessments at Kerpape CMRRF or Henry Gabrielle Hospital.

  2. Demographic factors associated with return to driving

    Time frame: From date of stroke to date of driving assessment in 2019, assessed retrospectively.

    Age, gender, and education level of stroke patients, analyzed according to the opinion of the multidisciplinary team and the registered physician (favorable, unfavorable, or favorable with restrictions).

  3. Clinical factors associated with return to driving

    Time frame: From date of stroke to date of driving assessment in 2019, assessed retrospectively.

    Clinical characteristics of stroke patients (stroke type, lesion side and date, comorbidities) analyzed according to the opinion of the multidisciplinary team and the registered physician (favorable, unfavorable, or favorable with restrictions).

Secondary outcomes

  1. Evaluate the maintenance of driving three years after a stroke and any changes in driving habits and/or practices, as well as driving habits and/or practices, as well as any new strategies brought about.

    Time frame: From end of 2019 assessment to date of telephone questionnaire in 2022, assessed prospectively.

    This questionnaire will be sent to patients to gather information on their driving habits, limitations, fears and driving strategies.

    The aim is not to focus on the problem of accidents in post-stroke patients. Rather, the aim is to find out whether they were able to maintain their driving activity despite the onset of a stroke, and to identify any driving difficulties they encountered. We also want to see whether they have changed their driving habits and/or implemented new strategies. The demographic and clinical information we obtain about them will also enable us to identify the most influential factors in the recovery process.

Sponsors and collaborators

Lead sponsor

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Other

Registry information

Official study title

RETROUVE : Study of the Return to Driving in People Who Have Suffered a Cerebrovascular Accident (CVA)

Acronym: RETROUVE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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